Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage
Rotavirus is the most common aetiology of acute gastroenteritis (AGE) in young children. Even though antibiotics are not part of the treatment regimen of rotavirus infection, acute gastroenteritis remains a common reason for antibiotic use especially in low-income settings. Antibiotic use can lead to numerous undesired effects in young children, including selection of antibiotic-resistant organisms and the unwanted development of colonization or infection with organisms with antimicrobial resistance (AMR). The sustained and dramatic rises in infections due to pathogens with AMR are leading to longer hospital stays, higher medical costs, and increased mortality globally. Hence, this study hypothesize that effective rotavirus vaccination can reduce diarrheal episodes and the associated indiscriminate antibiotic usage in young children in low-income settings. The evidence-based data generated from this study would inform policy-makers seeking to introduce new rotavirus vaccines into national vaccination programmes, of potential, and often under-appreciated, secondary effects of rotavirus vaccine implementation on antibiotic usage.
This study seeks to answer research questions added on as additional endpoints to an ongoing phase III randomised controlled trial comparing the efficacy of a new parenteral trivalent P2-VP8* subunit rotavirus vaccine to the oral live attenuated vaccine, Rotarix® against severe RV gastroenteritis in Ghana and Zambia.
The primary objectives of the study are to: i) evaluate the impact of differences in rotavirus vaccine efficacy on antibiotic usage in African infants; ii) assess how intestinal bacterial microbiome composition correlate with rotavirus vaccine efficacy and true protection from disease; iii) assess whether there is any correlation between intestinal bacterial microbiome composition and P2-VP8* subunit vaccine immunogenicity and efficacy against rotavirus gastroenteritis.
The secondary objectives include: i) the assessment of the background incidence of antibiotic usage in the community in the first two years of life; ii) assessment of the relationship between frequency of antibiotic use and faecal bacterial microbiome composition, antimicrobial resistance gene abundance and bacterial metabolites in the urine over the first two years of life.
This research is important because it will: i) quantify the number of days of antibiotic use in the most vulnerable of infant population ii) relate the quantification of antibiotic use to preventive measures, specifically vaccination iii) demonstrate what the impact of antibiotic use is on the development of the infant microbiome and the carriage of bacteria with pathogenic populations in young children in African settings.